HealthyNCT05904418
Robot-Assisted US-Based Vertebral Segmentation for Pedicle Screw Trajectory Identification
A study testing Robot-assisted US Scan of the vertebra L1 to S1, Handheld US scan of the vertebra L1 to S1 and ULD CT scan of the vertebra L1 to S1 in people with Healthy, run by Philipp Fürnstahl at 1 site in Switzerland.
Trial summary
This other clinical trial compares robot-assisted US scanning with handheld US scanning and ground-truth CT data of the lumbar spine in healthy, young volunteers. The main questions it aims to answer are: Is a 3D reconstruction of a lumbar spine from robot-assisted US scanning equivalent to or better quality than a 3D… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Robot-assisted US Scan of the vertebra L1 to S1, Handheld US scan of the vertebra L1 to S1 and ULD CT scan of the vertebra L1 to S1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 May 2023to 9 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Oral and written informed consent from the volunteer
- Volunteers aged ≥18 y/o and ≤35 y/o
- BMI above or equal to 19 kg/m2 or below or equal to 25 kg/m2
- Proficient in German or English language
Who cannot join
- Documented volunteer refusal
- Volunteers in whom CT cannot be performed
- Positive pregnancy test prior to radiology (contraindication to CT)
- Pregnancy
- Chronic pain in the lumbar spine
- Moderate or severe deformity of the lumbar spine
Show all 13Show fewer
- Any prior intervention to the lumbar spine:
- Chiropractic adjustment therapy
- Injections such as local anesthetics and corticosteroids
- Surgery
- Fracture of the lumbar spine
- BMI below 19 kg/m2 or above 25 kg/m2
- Anatomies, such as subcutaneous fat or tendon, occlude the bony surface or do not allow a clear image in the US scan
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Balgrist, Balgrist Campus
Zurich, 8008
About this study
Official title: Robot-Assisted US-Based Vertebral Segmentation for Pedicle Screw Trajectory Identification: A Comparison With Handheld US-Reconstructions and Ground Truth CT-Data
This other clinical trial compares robot-assisted US scanning with handheld US scanning and ground-truth CT data of the lumbar spine in healthy, young volunteers. The main questions it aims to answer are:
- Is a 3D reconstruction of a lumbar spine from robot-assisted US scanning equivalent to or better quality than a 3D reconstruction from handheld US scanning?
- Can a machine learning algorithm automatically segment the bone anatomy from robot-assisted and handheld US scanning to generate 3D lumbar spine reconstructions?
- Can pedicle screw trajectories be identified based on posterior vertebral landmarks of 3D reconstructions of lumbar spines from both robot-assisted and handheld US scanning?
Read more
Participants will:
- fill out a medical history questionnaire
- get clinically examined
- have an ultra-low-dose (ULD) CT Scan of the vertebra L1 to S1
- have a handheld US scan of the vertebra L1 to S1
- have a robot-assisted US Scan of the vertebra L1 to S1
- fill out a post-study questionnaire
Read the detailed description
The following hypotheses are tested:
- A 3D reconstruction of a lumbar spine from robot-assisted US scanning is equivalent to or of better quality than a 3D reconstruction handheld US scanning.
- A machine learning algorithm can automatically segment the bone anatomy from robot-assisted and handheld US scanning to generate said 3D lumbar spine reconstructions.
- Pedicle screw trajectories can be identified based on posterior vertebral landmarks of 3D reconstructions of lumbar spines from robot-assisted and handheld US scanning.
The project consists of three pillars as objectives to help solidify the US reconstruction of the lumbar spine as a novel navigational method in interventional spine applications.
- 1st Pillar: A first-of-a-kind in-vivo robot-assisted and handheld US reconstruction dataset of the lumbar spine in healthy subjects is acquired. The collected dataset is compared to ground truth CT data to assess quality.
- 2nd Pillar: A novel machine learning algorithm is trained to segment the US reconstructions of all the collected lumbar spine data into each identified vertebra.
- 3rd Pillar: A novel measurement method to identify pedicle screw trajectories based on posterior vertebral landmarks is applied to the segmented US reconstructions. This research further promotes US for future use in robot-assisted interventions.
This project consists of two phases. First, a preliminary pilot study is planned to assess the project's feasibility and improve the planned workflow and safety measures. For this pilot, the investigators will mouth-to-mouth recruit two volunteers. After completing and thoroughly evaluating the pilot, the investigators will conduct the actual study.
The volunteers for the actual study are selected through public calls for participation. Possible volunteers are young, healthy, and not affected by illness or deformation of the lumbar spine. The selected volunteers are screened by asking about their medical history. If included and willing to participate, the volunteers are invited to the study at Balgrist Campus and will be clinically examined regarding the lumbar spine. Furthermore, a low-dose CT scan, a handheld US scan, and a robot-assisted US scan are held.
The CT scans are manually segmented into 3D surface models to obtain a "segmentation ground truth". A novel machine learning algorithm automatically performs 3D reconstruction and segments the robot-assisted and handheld US scans.
The 3D US reconstructions are then utilized to identify pedicle screw trajectories through a novel method based on the posterior anatomical landmarks of lumbar vertebrae.
This single-center study combines the clinical and computer-science knowledge from the Research in Orthopedic Computer Science (ROCS) team of the University of Zurich, Switzerland, with the robotics and US application knowledge from the Faculty of Engineering of the University of Leuven, Belgium. The data collection is performed at Balgrist Campus.
- Conditions
- Healthy
- Being tested
- Robot-assisted US Scan of the vertebra L1 to S1, Handheld US scan of the vertebra L1 to S1, ULD CT scan of the vertebra L1 to S1
- Keywords
- lumbar spine, healthy, young volunteers, handheld ultrasound scan, robot-assisted ultrasound scan, CT scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted US Scan of the vertebra L1 to S1Other
A standardized robot-assisted US-Scan of the vertebra L1 to the S1 is executed. The two probe trajectories are generated automatically by an optical camera or RedGreenBlue-Depth (RGB-D) camera. Then the robot will scan at two mm/s, automatically following the trajectory. A 6 degrees of freedom (DoF) force sensor (Nano25, Ati Industrial Automation Inc.) was assembled at the US probe. During the scanning, it measures the interaction force and torque between the US probe and volunteers' skin to ensure volunteer safety. The US images and corresponding robot poses are recorded for the reconstruction. A previously developed algorithm is used to obtain a preliminary 3D reconstruction that will be used to adapt the scanning pattern in case of incomplete scanning.
Handheld US scan of the vertebra L1 to S1Other
A handheld US-Scan of the vertebra L1 to S1 is executed. An optical marker for an Atracsys Camera is mounted to the US probe to track its position. Simultaneously, the optical tracking allows for standardization of the US-Scan through navigation. The acquired US images and corresponding poses are used to reconstruct the lumbar spines and compared to the ground truth (CT scan). Handheld US scanning will be performed at around two mm/s in two scanning trajectories. The US probe orientation will be adjusted during the scanning by comparing the optical marker orientation with the initial probe orientation. This combination leads to different scanning patterns. For each pattern, the scanning procedure will be repeated three times. At least once per volunteer, each handheld scanning pattern will be performed with a higher manual speed to assess the reconstruction quality with faster scanning. A graphical user interface (GUI) will synchronize and store the data during the scanning.
ULD CT scan of the vertebra L1 to S1Radiation
A ULD CT scan (CT, Siemens Naeotom Alpha: A-207883-62) of the lumbar spine (L1-S1) is performed at the Swiss Center for Musculoskeletal Imaging (SCMI) at Balgrist Campus, Zurich. The total duration estimate for the CT examination is 30 minutes, whereas the scan takes 15 minutes. The volunteers lie on their abdomen during this procedure to simulate the spine's position during the subsequent US examination. The vertebrae (L1-S1) in the CT Scans are manually segmented with global thresholding and the region growing tool in a standard segmentation software (Materialise Mimics, Leuven, Belgium). The 3D surface models are then exported as Standard Triangle Language (STL) files.
| Study group | Role | What they receive |
|---|---|---|
| Young, healthy volunteers | Other | 1. Medical History (20 minutes)
2. Clinical examination (20 minutes)
3. Clothes changing time (15 minutes)
4. ULD CT scan of the vertebra L1 to S1 (30 minutes)
5. Clothes changing time (15 minutes)
6. Handheld US scan of the vertebra L1 to S1 (20 minutes)
7. Platform changing time (15 minutes)
8. Path planning and robot-assisted US Scan of the vertebra L1 to S1 (40 minutes)
9. Clothes changing time (15 minutes)
10. Volunteer Questionnaire (10 minutes)
Total study time per volunteer: 3 Hours 20 minutes Receives: Other: Robot-assisted US Scan of the vertebra L1 to S1; Other: Handheld US scan of the vertebra L1 to S1; Radiation: ULD CT scan of the vertebra L1 to S1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target registration errors between US reconstructions and ground truth CT data
Evaluating the accuracy of the US reconstructions
Measured: Up to 1 year
Pedicle screw placement - Trajectory errors in terms of position
Evaluating the positional accuracy of the Pedicle screw placement
Measured: Up to 1 year
Pedicle screw placement - Trajectory errors in terms of direction
Evaluating the directional accuracy of the Pedicle screw placement
Measured: Up to 1 year
Secondary outcomes (6)
Gender
female, male, non-binary, do not know, other
Measured: Up to 4 weeks
Age
in years
Measured: Up to 4 weeks
Smoking status
yes/no; if yes, pack years
Measured: Up to 4 weeks
BMI
weight and height
Measured: Up to 4 weeks
Tegner activity score
Subjective activity score of the volunteers
Measured: Up to 4 weeks
ODI Oswestry Low Back Pain Disability Index
Standardized Low Back Pain Disability Index
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 May 2023
- Primary completion9 Jun 2023
- Study completion9 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants have to go through the previously mentioned interventions
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipp Fürnstahl
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Center for Musculoskeletal Imaging, KU Leuven
- Responsible party
- Sponsor-investigator, Philipp Fürnstahl, Balgrist University Hospital
- Investigators
- Philipp Fürnstahl, PhD, Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904418
- Sponsor's protocol ID
- W1001
- Status last verified
- Jun 2023
- First submitted
- 3 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completing our analysis, we plan to make the dataset of robot-assisted US Reconstructions available to other research groups. The individual participant data (IPD) will be stored in a data repository.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Assisted US-Based Vertebral Segmentation for Pedicle Screw Trajectory Identification: A Comparison With Handheld US-Reconstructions and Ground Truth CT-Data
- ClinicalTrials.gov ID
- NCT05904418
- Acronym / sponsor ID
- W1001
- Conditions
- Healthy
- Keywords
- lumbar spine, healthy, young volunteers, handheld ultrasound scan, robot-assisted ultrasound scan, CT scan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Philipp FürnstahlUniversity, hospital or other
- Collaborators
- Swiss Center for Musculoskeletal Imaging, KU Leuven
- Study start
- 15 May 2023 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This other clinical trial compares robot-assisted US scanning with handheld US scanning and ground-truth CT data of the lumbar spine in healthy, young volunteers. The main questions it aims to answer are:
- Is a 3D reconstruction of a lumbar spine from robot-assisted US scanning equivalent to or better quality than a 3D reconstruction from handheld US scanning?
- Can a machine learning algorithm automatically segment the bone anatomy from robot-assisted and handheld US scanning to generate 3D lumbar spine reconstructions?
- Can pedicle screw trajectories be identified based on posterior vertebral landmarks of 3D reconstructions of lumbar spines from both robot-assisted and handheld US scanning?
Participants will:
- fill out a medical history questionnaire
- get clinically examined
- have an ultra-low-dose (ULD) CT Scan of the vertebra L1 to S1
- have a handheld US scan of the vertebra L1 to S1
- have a robot-assisted US Scan of the vertebra L1 to S1
- fill out a post-study questionnaire
Detailed description
The following hypotheses are tested:
- A 3D reconstruction of a lumbar spine from robot-assisted US scanning is equivalent to or of better quality than a 3D reconstruction handheld US scanning.
- A machine learning algorithm can automatically segment the bone anatomy from robot-assisted and handheld US scanning to generate said 3D lumbar spine reconstructions.
- Pedicle screw trajectories can be identified based on posterior vertebral landmarks of 3D reconstructions of lumbar spines from robot-assisted and handheld US scanning.
The project consists of three pillars as objectives to help solidify the US reconstruction of the lumbar spine as a novel navigational method in interventional spine applications.
- 1st Pillar: A first-of-a-kind in-vivo robot-assisted and handheld US reconstruction dataset of the lumbar spine in healthy subjects is acquired. The collected dataset is compared to ground truth CT data to assess quality.
- 2nd Pillar: A novel machine learning algorithm is trained to segment the US reconstructions of all the collected lumbar spine data into each identified vertebra.
- 3rd Pillar: A novel measurement method to identify pedicle screw trajectories based on posterior vertebral landmarks is applied to the segmented US reconstructions. This research further promotes US for future use in robot-assisted interventions.
This project consists of two phases. First, a preliminary pilot study is planned to assess the project's feasibility and improve the planned workflow and safety measures. For this pilot, the investigators will mouth-to-mouth recruit two volunteers. After completing and thoroughly evaluating the pilot, the investigators will conduct the actual study.
The volunteers for the actual study are selected through public calls for participation. Possible volunteers are young, healthy, and not affected by illness or deformation of the lumbar spine. The selected volunteers are screened by asking about their medical history. If included and willing to participate, the volunteers are invited to the study at Balgrist Campus and will be clinically examined regarding the lumbar spine. Furthermore, a low-dose CT scan, a handheld US scan, and a robot-assisted US scan are held.
The CT scans are manually segmented into 3D surface models to obtain a "segmentation ground truth". A novel machine learning algorithm automatically performs 3D reconstruction and segments the robot-assisted and handheld US scans.
The 3D US reconstructions are then utilized to identify pedicle screw trajectories through a novel method based on the posterior anatomical landmarks of lumbar vertebrae.
This single-center study combines the clinical and computer-science knowledge from the Research in Orthopedic Computer Science (ROCS) team of the University of Zurich, Switzerland, with the robotics and US application knowledge from the Faculty of Engineering of the University of Leuven, Belgium. The data collection is performed at Balgrist Campus.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants have to go through the previously mentioned interventions
| Arm | Type | Receives |
|---|---|---|
| Young, healthy volunteers | Other | Other: Robot-assisted US Scan of the vertebra L1 to S1, Other: Handheld US scan of the vertebra L1 to S1, Radiation: ULD CT scan of the vertebra L1 to S11. Medical History (20 minutes) 2. Clinical examination (20 minutes) 3. Clothes changing time (15 minutes) 4. ULD CT scan of the vertebra L1 to S1 (30 minutes) 5. Clothes changing time (15 minutes) 6. Handheld US scan of the vertebra L1 to S1 (20 minutes) 7. Platform changing time (15 minutes) 8. Path planning and robot-assisted US Scan of the vertebra L1 to S1 (40 minutes) 9. Clothes changing time (15 minutes) 10. Volunteer Questionnaire (10 minutes) Total study time per volunteer: 3 Hours 20 minutes |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Oral and written informed consent from the volunteer
- Volunteers aged ≥18 y/o and ≤35 y/o
- BMI above or equal to 19 kg/m2 or below or equal to 25 kg/m2
- Proficient in German or English language
Key exclusion criteria (13 listed)
- Documented volunteer refusal
- Volunteers in whom CT cannot be performed
- Positive pregnancy test prior to radiology (contraindication to CT)
- Pregnancy
- Chronic pain in the lumbar spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted US Scan of the vertebra L1 to S1A standardized robot-assisted US-Scan of the vertebra L1 to the S1 is executed. The two probe trajectories are generated automatically by an optical camera or RedGreenBlue-Depth (RGB-D) camera. Then the robot will scan at two mm/s, automatically following the trajectory. A 6 degrees of freedom (DoF) force sensor (Nano25, Ati Industrial Automation Inc.) was assembled at the US probe. During the scanning, it measures the interaction force and torque between the US probe and volunteers' skin to ensure volunteer safety. The US images and corresponding robot poses are recorded for the reconstruction. A previously developed algorithm is used to obtain a preliminary 3D reconstruction that will be used to adapt the scanning pattern in case of incomplete scanning. | Other | Young, healthy volunteers |
| Handheld US scan of the vertebra L1 to S1A handheld US-Scan of the vertebra L1 to S1 is executed. An optical marker for an Atracsys Camera is mounted to the US probe to track its position. Simultaneously, the optical tracking allows for standardization of the US-Scan through navigation. The acquired US images and corresponding poses are used to reconstruct the lumbar spines and compared to the ground truth (CT scan). Handheld US scanning will be performed at around two mm/s in two scanning trajectories. The US probe orientation will be adjusted during the scanning by comparing the optical marker orientation with the initial probe orientation. This combination leads to different scanning patterns. For each pattern, the scanning procedure will be repeated three times. At least once per volunteer, each handheld scanning pattern will be performed with a higher manual speed to assess the reconstruction quality with faster scanning. A graphical user interface (GUI) will synchronize and store the data during the scanning. | Other | Young, healthy volunteers |
| ULD CT scan of the vertebra L1 to S1A ULD CT scan (CT, Siemens Naeotom Alpha: A-207883-62) of the lumbar spine (L1-S1) is performed at the Swiss Center for Musculoskeletal Imaging (SCMI) at Balgrist Campus, Zurich. The total duration estimate for the CT examination is 30 minutes, whereas the scan takes 15 minutes. The volunteers lie on their abdomen during this procedure to simulate the spine's position during the subsequent US examination. The vertebrae (L1-S1) in the CT Scans are manually segmented with global thresholding and the region growing tool in a standard segmentation software (Materialise Mimics, Leuven, Belgium). The 3D surface models are then exported as Standard Triangle Language (STL) files. | Radiation | Young, healthy volunteers |
Primary outcome
Target registration errors between US reconstructions and ground truth CT data
Time frame: Up to 1 year
Evaluating the accuracy of the US reconstructions
Pedicle screw placement - Trajectory errors in terms of position
Time frame: Up to 1 year
Evaluating the positional accuracy of the Pedicle screw placement
Pedicle screw placement - Trajectory errors in terms of direction
Time frame: Up to 1 year
Evaluating the directional accuracy of the Pedicle screw placement
6 secondary outcomes
Gender
Time frame: Up to 4 weeks
Age
Time frame: Up to 4 weeks
Smoking status
Time frame: Up to 4 weeks
BMI
Time frame: Up to 4 weeks
Tegner activity score
Time frame: Up to 4 weeks
ODI Oswestry Low Back Pain Disability Index
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Yes. After completing our analysis, we plan to make the dataset of robot-assisted US Reconstructions available to other research groups. The individual participant data (IPD) will be stored in a data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Fürnstahl, PhD principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted US Scan of the vertebra L1 to S1, Handheld US scan of the vertebra L1 to S1 and ULD CT scan of the vertebra L1 to S1 in people with Healthy, run by Philipp Fürnstahl at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target registration errors between US reconstructions and ground truth CT data (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.